PMA P160021

Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P160021
Supplement: S036
Product code: PRL
Decision date: 2026-10-08
Generic name: Iliac covered stent, arterial
Approval order statement: expanding the indications to include use as a bridging stent to maintain visceral artery perfusion in fenestrated and branched endovascular aortic aneurysm repair (FEVAR and BEVAR)

Current openFDA PMA Record#

Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P160021
Supplement: S051
Product code: PRL
Generic name: Iliac covered stent, arterial
Decision date: 2026-10-08
Decision code: APPR
Date received: 2026-02-06
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: expanding the indications to include use as a bridging stent to maintain visceral artery perfusion in fenestrated and branched endovascular aortic aneurysm repair (FEVAR and BEVAR)